BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAVUX CERVICAL CAGE-X

    MDR report key: 15396625 · Received September 9, 2022

    Report

    Report Number
    3009394448-2022-00004
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 16, 2022
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC
    Product Code
    ODP
    PMA / PMN Number
    K122801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS NO DEVICE MALFUNCTION AND REMOVAL WAS NOT DUE TO FAILURE OF DEVICE. THE INDEX PROCEDURE WAS A ONE LEVEL STAND ALONE PCF AT C4-C5 ON (B)(6) 2022. INDEX PROCEDURE OUTCOME WAS AS EXPECTED. POST INDEX PROCEDURE, PATIENT SUFFERED A FACET FRACTURE, CAUSING A FRAGMENT OF BONE TO MOVE INTO THE FORAMEN. REVISION PROCEDURE ON (B)(6) 2022 WAS A SUCCESSFUL FORAMINOTOMY TO RETRIEVE BONE FRAGMENT AND REMOVE CERVICAL CAGE. NO NEGATIVE CLINICAL SEQUALAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360233 CAVUX CERVICAL CAGE-X CERVICAL CAGE ODP PROVIDENCE MEDICAL TECHNOLOGY, INC PD-31-203 CX222201

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention